EDURANT PACKAGE INSERT PDF

Drug information on Rilpivirine Tablet (film coated) for health care professionals. Edurant (rilpivirine) Tablets, Package Insert. EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse. For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg .. The interaction between rilpivirine and the medicinal product was evaluated in a clinical study. See package leaflet for further information.

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However, it may not be completely excluded that rilpivirine can increase the exposure to other medicines transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e. In the trials, the presence of the mutations V90I and VI, at baseline, did not affect response.

Most ADRs were Grade 1 or 2. After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within hours. There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults see sections 4. Steady-state administration of rilpivirine 75 mg once daily and mg once daily resulted in a mean C max approximately 2. The trials were identical in design, with the exception of eudrant background regimen BR.

HIV PIs — with co-administration of low dose ritonavir.

Edurant 25 mg tablets

In mice, rilpivirine was positive for hepatocellular neoplasms in both males and females. Most of these discontinuations occurred in the first 48 weeks of treatment.

Any unused medicinal product or waste material should edurnat disposed of in accordance with local requirements. Therapy should be pacoage by a physician experienced in the management of HIV infection.

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To bookmark a medicine you must sign up and log in. The European Medicines Agency has deferred the obligation to submit the results of studies with rilpivirine in one or more subsets of the paediatric population in the treatment of Human Immunodeficiency Virus HIV-1 infection see section 4.

Distribution Rilpivirine is approximately In the phase 3 studies, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely see sections edirant. There were no safety concerns identified in the week analyses.

Edurant (rilpivirine) Tablets, Package Insert | DAIDS Regulatory Support Center (RSC)

Active ingredient rilpivirine hydrochloride. The KN substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of KN and LI resulted packaage a 7-fold reduced susceptibility to rilpivirine.

Sign Up Log In Cancel. Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics are not different across the age range 18 to 78 years evaluated, with only 3 subjects aged 65 years or older.

Percentage of subjects with: The most common mutations were the same in the week 48 and week 96 analyses.

Medicinal products that are edhrant by the use of rilpivirine Rilpivirine at a dose of 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.

St John’s wort Hypericum perforatum.

Edurant 25 mg tablets – Summary of Product Characteristics (SmPC) – (eMC)

The most frequent serious treatment-related ADRs were reported in 7 1. Missed dose If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, the patient must take the packae with a meal as soon as possible and resume the normal dosing schedule.

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Each carton contains one bottle of 30 tablets. The clinical implications of this finding are currently unknown. Alternatively, switching to another ART regimen could be considered see sections 4.

Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to weeks. Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than the rilpivirine arm.

Edurant (rilpivirine) Tablets, Package Insert

Race Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine. Autoimmune disorders such as Graves’ disease and autoimmune hepatitis have also been reported; however, the reported time to onset is more variable and these events can occur many evurant after initiation of treatment see section 4.

Healthcare professionals are asked to report inserr suspected adverse reactions via:. Treatment of overdose with rilpivirine consists of general supportive measures including monitoring of vital signs and ECG QT interval as well as observation of the clinical status of the patient. Significant decreases in rilpivirine plasma concentrations are expected.